Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer

NCT02025712 | Unknown Phase 2 DMC

• 1 other identifier: M004/EXE-EVE
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  defined as from date of treatment initiation with everolimus plus exemestane to the date of progression or death if no documented disease progression

  Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)

Secondary Outcomes (4)

• Response rate

  Every 8 weeks, up to 8 months (estimated)

• Clinical benefit rate

  Every 8 weeks, up to 8 months (estimated)

• Overall survival

  date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months

• Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)

  Continuous during the study, up to 28 days after the last treatment

Study Arms (1)

Exemestane plus Everolimus

EXPERIMENTAL

Exemestane 25 mg daily in combination with Everolimus 10 mg daily until disease progression or intolerable toxicity

Drug: Exemestane; Drug: Everolimus

Interventions

Exemestane DRUG

Commercially available exemestane was supplied to sites as 25-mg tablets according to local regulations.

Also known as: Aromasin

Exemestane plus Everolimus

Everolimus DRUG

Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets.

Also known as: Afinitor, RAD001

Exemestane plus Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women as defined in the protocol page 9;
• Histologically and/or cytologically confirmed invasive breast cancer with stage IV disease according to AJCC;
• Confirmed ER/PR-positive, and HER-2 negative tumor;
• Disease progression on or following prior endocrine therapy with tamoxifen or non-steroidal aromatase inhibitor, as defined in protocol, prior to standard of care (SOC) induction chemotherapy
• Patient with documented evidence of visceral disease (including but not limited to hepatic involvement and pulmonary lymphangitic spread of tumor) with sign(s) and/or symptom(s) prior to SOC induction chemotherapy should achieve disease stabilization after the SOC induction chemotherapy, confirmed upon 2 consecutive routine tumor assessments;
• ECOG performance status ≤ 2 or Karnofsky performance status ≥ 50% prior to the start of study treatment;
• Adequate organ function prior to the start of study treatment as defined in the protocol;
• Able to swallow and retain oral medication;
• Able to give written informed consent;

You may not qualify if:

• Male patient;
• Metastatic disease limited to the bone or soft tissues only and with no history of other visceral metastases;
• History of brain or other CNS metastases;
• Previous treatment with exemestane, unless exemestane was administered in the adjuvant setting and stopped \>1 year before metastatic relapse;
• Untreated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC - or - treated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC without clinical benefit;
• History of neurological or psychiatric disorders;
• Any serious cardiovascular diseases in the previous 6 months;
• Impairment of gastrointestinal function or gastrointestinal disease;
• Patients with uncontrolled infection;
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin defined as 1 mg a day);
• Chronic treatment with systemic steroids or another immunosuppressive agent;
• Patients with a pre-existing peripheral neuropathy \> grade 1;
• Patients who are hepatitis B and/or hepatitis C carriers;
• Known human immunodeficiency virus infection;
• Prior exposure to mTOR inhibitors;

Sponsors & Collaborators

• Organisation for Oncology and Translational Research: lead

Study Sites (1)

Unimed Medical Institute

Hong Kong, China

Location

MeSH Terms

Interventions

exemestane; Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Louis Chow

  Organisation for Oncology and Translational Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Chow, MD

CONTACT

(852)28610286

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 1, 2014
• Primary Completion: August 1, 2016
• Last Updated: January 1, 2014

Record last verified: 2013-12

Locations

CN (1)